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Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder

Not Applicable
Active, not recruiting
Conditions
Bulimia Nervosa
Bulimia; Atypical
Binge Eating
Binge-Eating Disorder
Binge-Eating and Purging Type Anorexia Nervosa
Interventions
Behavioral: Behavioral Therapy for Eating Disorders
Registration Number
NCT04625959
Lead Sponsor
Drexel University
Brief Summary

The current study will use a full factorial design to identify the independent and combined effects of four core MABT components when combined with standard behavioral treatment for BN and BED. The primary aim of the study will be to evaluate the independent efficacy of Mindful Awareness, Distress Tolerance, Emotion Modulation, and Values-Based Decision Making on eating pathology (at posttreatment and at 6 and 12-month follow-ups). Secondary aims will be (1) to test target engagement of each MABT component, i.e., to confirm that each treatment component impacts both the variable which it targets and self-regulation and that improvements in these are associated with improvements in outcomes and (2) to test the hypotheses that the efficacy of each component is moderated by related baseline deficits in self-regulation (e.g. individuals with worse distress tolerance at baseline are most likely to benefit from conditions that include the Distress Tolerance component). A final exploratory aim will be to quantify the component interaction effects, which may be partially additive (because components overlap and/or there is diminishing return), fully additive, or synergistic (in that components may partially depend on each other).

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
256
Inclusion Criteria
  1. Have experienced 12 or more loss of control episodes within the previous 3 months
  2. Have a BMI above 16
  3. Are located in the US and wiling/able to participate in remote treatment and assessments
  4. Are able to give consent
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Exclusion Criteria
  1. Are unable to fluently speak, write and read English
  2. Have a BMI below 16
  3. Are receiving treatment for an eating disorder
  4. Require immediate treatment for medical complications as a result of eating disorder symptoms
  5. Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Base BTBehavioral Therapy for Eating Disorders16 weekly sessions of behavioral therapy.
Primary Outcome Measures
NameTimeMethod
Binge eating frequency assessed by the Eating Disorder ExaminationChanges from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6-month and 1 year post-treatment follow-up assessment

Frequency (number of days and number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination

Eating Disorder ExaminationChanges from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment

The Eating Disorder Examination is a semi-structured interview that measures eating pathology. The EDE yields four subscale scores: Restraint, Eating Concern, Shape Concern, and Weight Concern. The possible score range for each subscale is 0 to 6. The total score may also be reported (determined by averaging the subscale scores); the score range for the total score is also 0 to 6. For subscale scores and total score, higher scores indicate more severe pathology. The restraint sub-scale of the EDE will be used to assess utilization of skills related to reducing dietary restraint.

Remission StatusChanges from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment

Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.

Secondary Outcome Measures
NameTimeMethod
Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment

Frequency (number of days and number of instances) of compensatory behaviors assessed by the Eating Disorder Examination

BMIChanges from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment

kilogram/(meters\^2), this is an outcome measure for participants with anorexia nervosa, binge/purge type

Trial Locations

Locations (1)

Drexel University, Stratton Hall

🇺🇸

Philadelphia, Pennsylvania, United States

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